Brace Neutralizer
FDA 510(k) K932592 · Smith and Nephew Donjoy, Inc.
510(k) numberK932592
Submission
- Device name
- Brace Neutralizer
- Applicant
- Smith and Nephew Donjoy, Inc.
Carsbad, CA, US - Received
- May 28, 1993
- Decision date
- March 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
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| K252767 | actiTENS miniGZJ · Traditional | Sublimed | 01/16/2026SE |
| K252236 | CP Relief Wand Rx - TENS/NMESGZJ · Special | N & C Holdings, LLC | 08/15/2025SE |
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
| K241228 | TENSWaveGZJ · Abbreviated | Zynex Medical Officer | 08/27/2024SE |
| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
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| K962462 | Musclemax Plus Electrical Muscle StimulatorIPF · Traditional | 09/23/1996SE |
| K955057 | Model 1100 Cold Therapy DeviceILO · Traditional | 03/08/1996SN |
| K951350 | Musclesense Electromyography DeviceHCC · Traditional | 06/23/1995SE |
| K945687 | Rounded Cannulated Inside-Out (Rci) Acl ScrewHWC · Traditional | 06/22/1995SN |
| K946313 | Tibial Routers, Femoral Routers and Tube Graft SizerHRX · Traditional | 03/17/1995SE |
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Questions and answers
When was Brace Neutralizer cleared by the FDA?
Brace Neutralizer (K932592) received a 510(k) decision of Substantially Equivalent on March 18, 1994, 294 days after the submission was received.
What is the product code of K932592?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.